A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)
NCT ID: NCT00658762
Last Updated: 2012-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
286 participants
INTERVENTIONAL
2008-05-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PD 0332334 225 mg BID
PD 0332334
Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper
PD 0332334 300 mg BID
PD 0332334
Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
Paroxetine 20 mg q am
paroxetine
Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper
Placebo BID
Placebo
Capsules, oral, BID, 8 weeks, with 2 week taper
Interventions
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PD 0332334
Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper
PD 0332334
Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
paroxetine
Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper
Placebo
Capsules, oral, BID, 8 weeks, with 2 week taper
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have a HAM-A total score \>/= 20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of \>/= 9 and a Raskin Depression Scale score \</= 7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.
Exclusion Criteria
* Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder; Obsessive compulsive disorder; Panic disorder; Agoraphobia; Posttraumatic stress disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder; Alcohol or substance abuse or dependence unless in full remission for at least 6 months; Social anxiety disorder.
* Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia; Psychotic disorder; Delirium, dementia, amnestic and other clinically significant cognitive disorders; Bipolar or schizoaffective disorder; Cyclothymic disorder; Dissociative disorders.
* Antisocial or borderline personality disorder.
* Serious suicidal risk per the clinical investigator's judgment.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Glendale, California, United States
Pfizer Investigational Site
Orange, California, United States
Pfizer Investigational Site
Temecula, California, United States
Pfizer Investigational Site
Upland, California, United States
Pfizer Investigational Site
Wildomar, California, United States
Pfizer Investigational Site
Fort Myers, Florida, United States
Pfizer Investigational Site
Orange City, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Marietta, Georgia, United States
Pfizer Investigational Site
Greenwood, Indiana, United States
Pfizer Investigational Site
Wichita, Kansas, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Syracuse, New York, United States
Pfizer Investigational Site
Beachwood, Ohio, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Pfizer Investigational Site
Salem, Oregon, United States
Pfizer Investigational Site
Media, Pennsylvania, United States
Pfizer Investigational Site
Norristown, Pennsylvania, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Woodstock, Vermont, United States
Pfizer Investigational Site
Budapest, , Hungary
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A5361020
Identifier Type: -
Identifier Source: org_study_id